Module 12 Presentations

26/01/2024

Legal Basis established in PDUFA V

Guidance on Mandatory Data Submission •Draft Guidance – Feb 2012 •Final Guidance in 2015 •Established mandatory data submission in standardized format •eStudy Data Guidance in 2021 clarified expanded submission types

Therapeutic Area Standards Non-clinical Data Standards

The Organisation for Professionals in Regulatory Affairs

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Types of Data Standards Exchange Standard

An exchange standard describes a standard way of exchanging data between computer systems

Exchange standards may describe the data elements and relationships necessary to achieve the unambiguous exchange of information between disparate systems

•Health Level 7 (HL7) •Structured Product Labeling (SPL) •eCTD 4.0 (ICH) Examples include:

The Organisation for Professionals in Regulatory Affairs

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